MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG DAA DOUBLE OFFSET ADAPTER RIGHT 80/45; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 75102240

Device Problem Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2020

Event Type  malfunction  

Manufacturer Narrative

Complaint: case-(b)(4).

Event Description

It was reported that the locking mechanism between handle and broach is loosening.Fault in device was noticed during use.The procedure was completed with the same device.A delay of 30 min or less was reported.No patient harm was reported.

Manufacturer Narrative

It was reported that the locking mechanism between handle and broach is loose.The fault in device was noticed during use.The procedure was completed with the same device.A delay of 30 min or less and no patient harm was reported.The complaint device, used in treatment, was returned for investigation.A visual inspection was performed.The device shows very limited signs of use and no damage is observed on the connector site to the broach.Furthermore, the instrument was tested with a gauge whereby no deviation was detected.Two additional complaints were reported for batch a58224.However, only one complaint showed a comparable reported failure mode as the complained device.This is a known problem and corrective actions were performed.A review of the production documentation for the batch in scope does not indicate any manufacturing process error.Based on the performed investigations, the reported failure mode could be confirmed.Previous investigations demonstrated that under specific circumstances the double offset adapter 80/45 may disconnect from the rasp during backslapping.An optimized design of the device has been released in order to reduce the occurrence of this issue.This version of the device will be monitored for similar issues.Should additional information become available, this complaint will be reassessed.This investigation is considered closed.

• Brand Name: DAA DOUBLE OFFSET ADAPTER RIGHT 80/45
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11196387
• MDR Text Key: 227798763
• Report Number: 9613369-2021-00048
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00885556535394
• UDI-Public: 00885556535394
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75102240
• Device Catalogue Number: 75102240
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Manufacturer Received: 12/29/2020
• Initial Date FDA Received: 01/19/2021
• Supplement Dates Manufacturer Received: 05/07/2021
• Supplement Dates FDA Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1